Package Insert: Information for the Patient

Dexketoprofeno Qualigen 25 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

1.What is Dexketoprofeno Qualigen and for what it is used

2.What you need to know before starting to take Dexketoprofeno Qualigen

3.How to take Dexketoprofeno Qualigen

4.Possible adverse effects

5.Storage of Dexketoprofeno Qualigen

6.Contents of the package and additional information

Dexketoprofeno Qualigen is a pain reliever belonging to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is used to treat mild to moderate pain, such as muscle pain or joint pain, menstrual pain (dysmenorrhea), and toothache pain.

Do not take Dexketoprofeno Qualigen

• If you are allergic to dexketoprofen trometamol or any of the other components of this medication (listed insection 6);
• If you are allergic to acetylsalicylic acid or another nonsteroidal anti-inflammatory drug;
• If you have asthma or have had asthma attacks, acute allergic rhinitis (a short period of nasal mucosa inflammation), nasal polyps (fleshy formations in the nasal cavity due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing) or chest wheezing after taking acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drugs;
• If you have or have had in the past peptic ulcers, stomach or intestinal bleeding, or chronic digestive problems (e.g., indigestion, stomach burning);
• If you have had in the past stomach or intestinal bleeding or perforation due to previous use of nonsteroidal anti-inflammatory drugs (NSAIDs) used for pain;
• If you have chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• If you have severe heart failure, moderate to severe renal insufficiency, or severe liver insufficiency;
• If you have bleeding disorders or blood clotting disorders;
• If you are pregnant or breastfeeding;
• If you are under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dexketoprofeno Qualigen:

• If you are allergic or have had allergy problems in the past;
• If you have kidney, liver, or heart diseases (hypertension and/or heart failure), or have had any of these conditions in the past;
• If you are taking diuretics or have inadequate hydration and reduced blood volume due to excessive fluid loss (e.g., excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of strokes, or think you may be at risk of these conditions (e.g., high blood pressure, diabetes, high cholesterol, or smoker) consult this treatment with your doctor or pharmacist. Medications like Dexketoprofeno Qualigen may be associated with a small increased risk of suffering heart attacks ("myocardial infarction") or strokes ("cerebral vascular accident"). This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration;
• If you are anelderlypatient, you may be more likely to experience adverse effects (see section 4). If these occur, consult your doctor immediately;
• If you are a woman with fertility problems (Dexketoprofeno Qualigen may decrease your fertility, so do not take it if you are planning to become pregnant or undergoing fertility studies);
• If you have a disorder in blood production and cell formation;
• If you have systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases that affect connective tissue);
• If you have or have had in the past chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have or have had in the past gastrointestinal or intestinal disorders;
• If you are taking other medications that increase the risk of peptic ulcers or bleeding, for example, oral corticosteroids, some antidepressants (SSRI type), anticoagulants such as acetylsalicylic acid (aspirin) or warfarin. In these cases, consult your doctor before taking Dexketoprofeno Qualigen; your doctor may prescribe an additional medication to protect your stomach (e.g., misoprostol or other medications that block stomach acid production).

Children and adolescents

Do not take Dexketoprofeno Qualigen if you are under 18 years old.

Taking Dexketoprofeno Qualigen with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication. There are some medications that should not be taken together and other medications that may require a dose change if taken together.

Always inform your doctor, dentist, or pharmacist if, in addition to Dexketoprofeno Qualigen, you are taking any of the following medications:

Not recommended associations:

• Acetylsalicylic acid (aspirin), corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medications used to prevent blood clotting;
• Lithium, used to treat some mood disorders;
• Methotrexate, used to treat rheumatoid arthritis and cancer;
• Hydantoins and phenytoin, used to treat epilepsy;
• Sulfamethoxazole, used to treat bacterial infections.

Associations requiring caution:

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists, used to control high blood pressure and heart conditions;
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• Zidovudine, used to treat viral infections;
• Aminoglycoside antibiotics, used to treat bacterial infections;
• Chlorpropamide and glibenclamide, used to treat diabetes.

Associations to consider:

• Quinolones (e.g., ciprofloxacin, levofloxacin), used to treat bacterial infections;
• Ciclosporin or tacrolimus, used to treat autoimmune diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medications; that is, medications used to dissolve blood clots;
• Probenecid, used to treat gout;
• Digoxin, used to treat chronic heart failure;
• Mifepristone, used as an abortifacient (to interrupt pregnancy);
• SSRI-type antidepressants;
• Antiplatelet agents used to reduce platelet aggregation and blood clotting.

If you have any doubts about taking other medications with Dexketoprofeno Qualigen, consult your doctor or pharmacist.

Taking Dexketoprofeno Qualigen with food and drinks

Take the tablets with an adequate amount of water. Take the tablets with food, as this helps to reduce the risk of experiencing adverse effects in the stomach or intestines. However, in the case of acute pain, take the tablets on an empty stomach; that is, at least 30 minutes before meals, as this facilitates the medication's action a little more quickly.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take Dexketoprofeno Qualigen during pregnancy or breastfeeding. Consult your doctor or pharmacist before using any medication.

• Inform your doctor if you are pregnant or planning to become pregnant, as Dexketoprofeno Qualigen may not be suitable for you.
• Do not take Dexketoprofeno Qualigen if you are breastfeeding. Seek advice from your doctor.
• Do not take Dexketoprofeno Qualigen in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleeding and delay or prolong delivery. Do not take Dexketoprofeno Qualigen during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, Dexketoprofeno Qualigen may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Driving and operating machinery

Dexketoprofeno Qualigen may slightly affect your ability to drive and operate machinery, as it may cause drowsiness or dizziness as adverse effects of treatment. If you notice these effects, do not use machinery or drive until these symptoms disappear. Seek advice from your doctor.

Dexketoprofeno Qualigen contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose of Dexketoprofeno Qualigen you need may vary, depending on the type, intensity, and duration of pain. Your doctor will tell you how many tablets to take per day and for how long.

Generally, it is recommended to take 1 tablet (25 mg of dexketoprofeno) every 8 hours, without exceeding 3 tablets per day (75 mg).

If you are an elderly patient or suffer from kidney or liver disease, it is recommended to start therapy with a maximum of 2 tablets per day (50 mg).

In elderly patients, this initial dose can be increased later according to the general recommended dose (75 mg of dexketoprofeno) if Dexketoprofeno Qualigen has been well tolerated.

If your pain is intense and you need quick relief, take the tablets on an empty stomach (at least 30 minutes before eating) as they will be absorbed more easily (see section 2 “Taking Dexketoprofeno Qualigen with food and drinks”).

If you take more Dexketoprofeno Qualigen than you should

If you have taken too much medication, inform your doctor or pharmacist immediately or go to the emergency service of your nearest hospital. Please remember to always carry the medication box or this leaflet with you. In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 915620420, indicating the medication and the amount ingested.

If you forgot to take Dexketoprofeno Qualigen

Do not take a double dose to compensate for the missed doses. Take the next dose when it is due (according to section 3 “How to take Dexketoprofeno Qualigen”).

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Dexketoprofeno Qualigen can cause side effects, although not everyone will experience them.

The possible side effects are listed below in order of frequency. The following table indicates how many patients may experience these side effects:

Common side effects

Nausea and/or vomiting, stomach pain, diarrhea, digestive disorders (dyspepsia).

Uncommon side effects

Dizziness, vertigo, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flushes, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish sensation and chills, general discomfort.

Rare side effects

Peptic ulcer, perforation of a peptic ulcer or bleeding (which may manifest with vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g. swelling of ankles), laryngeal edema, loss of appetite (anorexia), abnormal sensation, pruritic rash, acne, increased sweating, lower back pain, frequent urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood analysis), inflammation of the liver (hepatitis), acute renal insufficiency.

Very rare side effects

Anaphylactic reaction (hypersensitivity reaction that may also lead to collapse), skin ulcers, mouth, eye, and genital area ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of the lips and throat (angioedema), difficulty breathing due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis inflammation, blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Inform your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g. stomach pain or burning, bleeding), if you have previously experienced any of these side effects due to prolonged treatment with anti-inflammatory agents, and especially if you areapatientofadvancedage.

Stop taking Dexketoprofeno Qualigen immediately if you notice the appearance of a skin rash or any lesions inside the mouth or on the genitals, or any other sign of allergy.

During treatment with nonsteroidal anti-inflammatory drugs, cases of fluid retention and swelling (especially in ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines like Dexketoprofeno Qualigen may be associated with a small increased risk of suffering a heart attack (“myocardial infarction”) or stroke (“cerebrovascular accident”).

In patients with autoimmune disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory drugs may rarely cause fever, headache, and neck stiffness.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Human Medicines website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and in the blister, after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dexketoprofeno Qualigen

• The active ingredient is dexketoprofen trometamol (36.90 mg) corresponding to 25 mg of dexketoprofen.
• The other components are: microcrystalline cellulose (E 460i), pregelatinized cornstarch, carboxymethyl sodium starch from potato, magnesium stearate (E 470b), hypromellose (E 464), polydextrose, titanium dioxide (E171) and macrogol 4000.

Appearance of the product and contents of the packaging

Dexketoprofeno Qualigen 25 mg is presented in the form of coated tablets. The tablets are round, with a notch and white in color. It is presented in packaging that contains 20, 50 tablets and a clinical packaging of 500 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona), Spain

Last review date of this leaflet: January 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS),http://www.aemps.gob.es/